Regulatory Affairs Associate

7 days ago

Toronto, Ontario, Canada Medison Pharma Full time

Medison is a global pharma company on a mission to help patients around the world get faster access to lifesaving, innovative, breakthrough therapies.

We operate in 4 continents and over 24 countries and are growing fast. If you want to be part of our mission and help save patients by getting them the latest treatments, join us


In your role as regulatory associate you will support multiple priority review NDS type submissions in rare disease and hematology and oncology.

In addition lead safety SNDSs and other minor regulatory submissions.


You will thrive in an environment of rapid change, demonstrate strong communication skills, work effectively within cross-functional teams, and have a problem-solving, analytical, and patient-centric mindset.


Requirements:

  • Minimum requirement Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, or equivalent experience
  • Minimum of 1years working in a regulatory affairs position with experience of the Canadian regulatory environment and Health Canada regulations, policies and guidelines.
  • Strong project and time management
  • Strong written and verbal communication skills
  • Interpersonal skills
  • Commitment to teamwork
  • Detail oriented
  • Proficient in the use of Microsoft Office
  • Patient and customer focused
  • Problem solving ability and innovative strategic thinking

Responsibilities:

  • Prepare, submit and support negotiations for approvals of postmarket submissions, e.g. SNDS-Labelling submissions (e.g. safety updates, new Product Monograph template conversions, Plain Language Labelling)
  • Maintain regulatory compliance of approved products (e.g. Annual Notifications, internal Level changes, postapproval commitments)
  • Support assessment and filing of CMC submissions (as assigned)
  • Assist with the submission review process with Health Canada (respond to clarifaxes)
  • Assist in implementing regulatory strategies and tactics
  • Support all aspects of the product labelling/artwork management process (as required)
  • Ensure regulatory submissions and documents are compliant with both HPFB and Medison requirements and standards (e.g., Electronic submission processes)
  • Provide comments and stay abreast on emerging Canadian regulations/policies/guidelines/initiatives/surveys

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